BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM

    MDR report key: 2202570 · Received August 5, 2011

    Report

    Report Number
    2024601-2011-00619
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ALLERGAN
    Product Code
    LTI
    PMA / PMN Number
    P000008
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EXAMINATION OF THE RETURNED DEVICE DETERMINED THE ACCESS PORT TUBING CONNECTOR TO BE A TAPER II. ALLERGAN HAS RECEIVED THE PRODUCT; HOWEVER, THE ANALYSIS HAS NOT BEEN COMPLETED AT THIS TIME. NO ADDITIONAL INFORMATION HAS BEEN REPORTED TO ALLERGAN REGARDING THE SERIAL NUMBER OF THE DEVICE. DEVICE LABELING ADDRESSES THE POSSIBLE OUTCOME OF LEAKAGE AS FOLLOWS: "DEFLATION OF THE BAND MAY OCCUR DUE TO LEAKAGE FROM THE BAND, THE PORT OR THE CONNECTOR TUBING."

    Description of Event or Problem · 1

    HEALTH PROFESSIONAL REPORTED THE REMOVAL OF A LAP-BAND ACCESS PORT DUE TO AN ALLEGED LEAK. THE LEAK WAS NOTED ON THE "PORT TUBING AND APPEARED TO BE WORN THROUGH AT THE SITE OF THE CONNECTOR." THE LEAK WAS FIRST NOTICED WHEN THE "PATIENT EXPERIENCED LOSS OF RESTRICTION AND CAME INTO THE CLINIC TO BE ASSESSED." AT THAT TIME, THE SURGEON ACCESSED THE PORT AND NOTED "FLUID WAS MISSING." THE SURGEON "WAS ABLE TO PULL BACK YELLOW COLORED FLUID." NO DIAGNOSTIC TESTING WAS DONE. THE PORT WAS REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM 10.0CM LTI ALLERGAN NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR CALCIUM| IBUPROFEN| VITAMINS| GLUCOSAMINE| PROZAC